MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN? EL ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	D141
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) and right ventricular (rv) lead exhibited out of range shock impedance measurements greater than 200 ohms, this was present at the last office interrogation.No adverse patient effects were reported.This device remains in service.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) and right ventricular (rv) lead exhibited out of range shock impedance measurements greater than 200 ohms, this was present at the last office interrogation.No adverse patient effects were reported.This device remains in service.Additional information was received that this icd was explanted approximately two months after this event.This device was received with no additional information.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) and right ventricular (rv) lead exhibited out of range shock impedance measurements greater than 200 ohms, this was present at the last office interrogation.No adverse patient effects were reported.This device remains in service.Additional information was received that this icd was explanted approximately two months after this event.This device was received with no additional information.The 'no problem detected' conclusion code was selected based on analysis of the returned product.Analysis found no evidence of device anomalies outside the bounds of normal medical use.

• Brand Name: INOGEN? EL ICD VR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 21256468
• Report Number: 2124215-2025-04166
• Device Sequence Number: 8038351
• Product Code: LWS
• UDI-Device Identifier: 00802526534225
• UDI-Public: (01)00802526534225(17)170217(21)189079
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/17/2017
• Device Model Number: D141
• Device Catalogue Number: D141
• Device Lot Number: 189079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 03/18/2025; 05/22/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 03/19/2025; 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male